Health TrialsbyHealthPanel

A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

ConditionOnychomycosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAmtixBio Co., Ltd.

About this trial

The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmation of onychomycosis by positive mycological (KOH) staining and positive culture from affected great toenail(s).

Appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s), as determined by visual inspection after the nail has been trimmed. If the percentage of infection is outside this range but is still considered appropriate for this study, based on the overall impression of the Principal Investigator (PI), participation can be considered in consultation with the Medical Monitor (MM). The visual inspection results of the appearance of onychomycosis involving 20% to 60% of 1 (or both) affected great toenail(s) will be reviewed by the Sponsor before enrollment.

The combined thickness of the distal nail plate at the associated hyperkeratotic nail bed is < 2 mm.

Adult males and females, 18 to 70 years of age (inclusive) at the time of Screening.

Disqualifiers

History of allergy to any of the excipients in ATB1651.

Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening or Day 1.

Underlying physical or psychological medical conditions that, in the opinion of the PI, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.

Unwilling to refrain from the use of nail cosmetics such as clear and/ or colored nail lacquers from the Screening visit until the end of the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ATB1651-102- Cohort 1

    Drug

    Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.

  • ATB1651-102- Cohort 2

    Drug

    Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 once daily to the affected great toenail for 20 weeks with a follow-up for 16 weeks.

  • ATB1651-102- Cohort 3

    Drug

    Dosage form- Topical solution; Dosage- 3% formulation The participants will apply the daily dose of 3% ATB1651 twice daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.

  • ATB1651-102- Cohort 4

    Drug

    Dosage form- Topical solution; Dosage- 5% formulation The participants will apply the daily dose of 5% ATB1651 once daily to the affected great toenail for 12 weeks with a follow-up for 24 weeks.

  • Placebo

    Drug

    participants will receive matching placebo across cohorts 1-4 of the study.

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: ATB1651-102 Cohort 1Experimental treatment 1 intervention
Group B: ATB1651-102 Cohort 2Experimental treatment 1 intervention
Group C: ATB1651-102 Cohort 3Experimental treatment 1 intervention
Group D: ATB1651-102 Cohort 4Experimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis.

Complete cure rate (defined as 100% clear nail surface area for the target toenail at Week 36 and negative mycological evaluation of the affected great toe after the last dosing).

Time frame
From screening to end of study treatment up to 252 days

Secondary outcomes

1

To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis.

Efficacy of ATB1651 assessed based on Mycological evaluation of the affected great toenail(s) where ATB1651 was applied. Standardized high-resolution photographs will also be taken and provided to a central reader to confirm the measurements Fungal growth will be measured for the affected great toenail(s) by direct mycological examination using staining (KOH) and culture of the nail scrapings for Trichophyton rubrum, Trichophyton mentagrophytes, Candida albicans, and other fungal species.

Time frame
From screening to end of study treatment up to 252 days
2

To assess and collect the percentage and severity of adverse events (AEs).

Adverse Events include changes pain, erythema and local irritation, and clinically significant results from physical examinations. AE will be coded using the most current version of Medical Dictionary for Regulatory Activities (MedDRA®) Version 22.0 or higher.

Time frame
From screening to end of study treatment up to 252 days
3

Maximum plasma concentration (Cmax)

Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 by CMAX of ATB1651

Time frame
Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140
4

Time to maximum plasma concentration (Tmax)

Pharmacokinetic profile characterized by systemic exposure following multiple doses of ATB1651 through Tmax of ATB1651

Time frame
Cohort 1, 3 and 4- On day1, day 14, day 28, day 42, Day 56, day 70 and day 84; Cohort 2- Same as cohort 1+day 98, 112, day 126 and day 140

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AmtixBio Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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